Lupin Receives US FDA Approval For Simvastatin Tablets

Lupin Pharmaceuticals, Inc. announced today that it has received final approval from the US FDA for its Abbreviated New Drug Application (ANDA) for Simvastatin Tablets 10mg, 20mg, 40mg and 80mg. Lupin's Simvastatin Tablets are the AB-rated generic equivalent of Merck's Zocor(R) tablets. Simvastatin is indicated for the treatment of high cholesterol. Vinita Gupta, President and Managing Director of Lupin Pharmaceuticals, Inc. commented, "We are delighted to receive final FDA approval for Simvastatin Tablets. The addition of generic Zocor(R) complements Lupin's commitment to bringing high-quality, low cost drug alternatives to the American public." With this approval, Lupin now has 21 ANDAs approved by the US FDA. About Lupin Headquartered in Mumbai, Lupin Ltd. is a leading pharmaceutical company with strong research focus. It has a program for developing New Chemical Entities. The Company has state-of-the-art R&D center in Pune. The Company is a leading global player in Anti-TB, Cephalosporins (anti-infectives) and Cardiovascular drugs (prils and statins) and has a notable presence in the areas of diabetology, NSAIDS and Asthma. For the financial year ended March 2007, Lupin's Revenues and Profit after Tax were Rs.20, 289 million (US$ 475 million) and Rs. 3,021 million (US$ 70 million) respectively. Lupin Pharmaceuticals, Inc. is the U.S. wholly owned subsidiary of Lupin Limited, which is among the top five Pharmaceutical companies in India. Through its sales and marketing headquarters in Baltimore, Maryland, Lupin Pharmaceuticals, Inc. is dedicated to delivering high-quality, affordable generic medicines trusted by healthcare professionals and patients across geographies. For more information, visit

(Author: http://www.lupinpharmaceuticals.com)

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